BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Genoray

    DI: 08809244060021 · Model: ZEN-2090 Pro · GENORAY CO., LTD.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Genoray
    Primary DI
    08809244060021
    Version / Model
    ZEN-2090 Pro
    Company Name
    GENORAY CO., LTD.
    Labeler DUNS
    631064672
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    4
    Public Version Date
    2023-12-08
    Public Version Status
    Update
    Public Device Record Key
    f2afe5f3-1f05-48a4-8e11-c87619c783d6

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
    JAA System, X-Ray, Fluoroscopic, Image-Intensified

    GMDN Terms

    Code Name
    37649 Portable general-purpose fluoroscopic x-ray system, digital

    Identifiers

    Type ID
    Primary 08809244060021

    Premarket Submissions

    Submission Number Supplement Number
    K091918 000